MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC ELECTRODE - ADAPTER - LEAD WIRE

Model Number	02-00139
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Rash (2033); Skin Inflammation/ Irritation (4545)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2024, the patient was experiencing a rash while wearling the lead wire adapater (lwa).The patient noted that the the rash had spread to the nipple/breast area and bruising was present.They were experiencing bleeding, scrappiness, oozing and rawness that is very painful.The patient contacted their dermatologist regarding the rash and they were prescribed doxycycline to take to relieve irritation.The patient's cardiologist advised the patient to continue monitoring.The patient reported that they have numerous allergies to triple ointment ingredients and latex and a mild adhesive allergy.It is thought the skin irritation is due to the electrodes.
Additional Manufacturer Narrative
It was reported that the patient experienced severe skin irritation while wearing the lead wire adapter.The device was not returned for investigation.Engineering evaluation was unable to be performed on the electrode as it is single use and was not returned.Allegation is confirmed prescription from a medical professional and is most probable to be a bio-incompatibility issue with the electrode adhesive and/or hydrogel components.Marsi, skin burn, and associated symptoms may inherently occur under the course of ecg monitoring.No single factor or combination of factors can be attributable to electrode skin irritation and associated symptoms.The product labeling advises patients of alternate options and other steps to take if skin irritation develops, including healthcare professional contact as needed.

• Brand Name: ELECTRODE - ADAPTER - LEAD WIRE
• Common Device Name: ELECTRODE - ADAPTER - LEAD WIRE
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer (Section G): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; suite 150; eagan, MN 55121 ; 6512968630
• MDR Report Key: 18935598
• Report Number: 2133409-2024-00020
• Device Sequence Number: 20575865
• Product Code: DSI
• UDI-Device Identifier: B146BTPL20
• UDI-Public: B146BTPL20
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K081444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 02-00139
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/29/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 01-02108, ELECTRODE - PAD - FOAM - VERMED A10091
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 20 YR
• Patient Sex: Female